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SM-020 Gel for Skin Cancer and Seborrheic Keratosis

Phase 2
Recruiting
Research Sponsored by DermBiont, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be at least 18 years of age
Subjects must have technical ability to apply treatment to all enrolled lesions
Must not have
Subjects who are pregnant, lactating, or female of childbearing potential not using active birth control methods
SK lesions that are clinically atypical and/or rapidly growing in size or number
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, baseline, week 1, week 2, week 3, week 4, week 6, and week 8
Awards & highlights

Summary

This trial will test the safety and effectiveness of SM-020 Gel 1.0% on subjects with Seborrheic Keratoses and Non-Melanoma Skin Cancers. Subjects will

Who is the study for?
This trial is for individuals with Seborrheic Keratoses and Non-Melanoma Skin Cancers, including Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ. Participants should have at least one eligible lesion but no more than five lesions in total to be treated.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a gel called SM-020 Gel 1.0% on skin conditions like Seborrheic Keratoses and certain types of skin cancer. It's an open-label trial where subjects apply the gel twice daily for about 28 days across different cohorts.See study design
What are the potential side effects?
While specific side effects are not listed, typical reactions to topical treatments may include skin irritation, redness, itching, or allergic reactions at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can apply treatment to all my lesions by myself.
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I have a confirmed diagnosis of seborrheic keratosis, basal cell carcinoma, or squamous cell carcinoma in situ.
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My skin growth is not near my eye and matches certain thickness and appearance criteria.
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I am willing to have all my skin lesions surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, and if capable of becoming pregnant, I am using birth control.
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My skin lesions are unusual or growing quickly.
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I have multiple sudden skin growths.
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I have or had cancer that affects my immune system.
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I am not on certain medications that are not allowed in the study.
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I am currently taking medication that increases my sensitivity to sunlight or affects how my body processes drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, baseline, week 1, week 2, week 3, week 4, week 6, and week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, baseline, week 1, week 2, week 3, week 4, week 6, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of lesions that achieve a 50% reduction in greatest diameter of cohort-assigned TL(s) at week 6 compared to baseline
Safety and Tolerability as evaluated by review of adverse events
Safety and Tolerability will be evaluated through assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment1 Intervention
Cohort 5: SM-020 gel 1.0% BID for 28 days to SKs
Group II: Cohort 4Experimental Treatment1 Intervention
Cohort 4: SM-020 gel 1.0% BID for 28 days to SCCISs
Group III: Cohort 3Experimental Treatment1 Intervention
Cohort 3: SM-020 gel 1.0% BID for 28 days to infiltrating BCCs
Group IV: Cohort 2Experimental Treatment1 Intervention
Cohort 2: SM-020 gel 1.0% BID for 28 days to nodular BCCs
Group V: Cohort 1Experimental Treatment1 Intervention
Cohort 1: SM-020 gel 1.0% BID for 28 days to superficial BCCs

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Who is running the clinical trial?

DermBiont, Inc.Lead Sponsor
13 Previous Clinical Trials
691 Total Patients Enrolled
~21 spots leftby Nov 2024